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Xanodyne Pharmaceuticals, Inc. to Voluntarily Withdraw Darvon(R) and Darvocet-N(R) Products



11/19/2010 9:01:26 AM

NEWPORT, Ky., Nov 19, 2010 (BUSINESS WIRE) -- Xanodyne Pharmaceuticals, Inc. announced today that the company will voluntarily withdraw its Darvon(R), Darvon-N(R), and Darvocet-N(R) products from the U.S. market in consultation with the U.S. Food and Drug Administration (FDA).

This withdrawal is part of a market-wide withdrawal applying to all propoxyphene-containing products, affecting branded and generic pharmaceutical companies and a number of products on the market.

Propoxyphene is a mild opiate used for the treatment of mild-to-moderate pain and has been on the U.S. market for the last 50 years.

On January 30, 2009, a meeting of the FDA Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was convened to review the efficacy and safety of propoxyphene-containing products. Following that meeting, Xanodyne agreed to work together with the FDA, and took a number of steps including developing a patient medication guide, strengthening several of the warnings in the product labeling, and conducting a clinical study to assess the maximum tolerated dose and effects of propoxyphene on cardiac conduction.

As a result of the availability and ongoing analysis of drug safety surveillance data and developing clinical information about the effects of propoxyphene on cardiac conduction, the FDA has determined that the benefits of propoxyphene-containing products no longer outweigh the potential risks. Patients should consult their physicians for instructions on how to safely transition to appropriate alternatives. For further information, patients can call Xanodyne's medical information line in the United States at 1 (877) 773 7793 or visit www.xanodyne.com.

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